Nevin Manimala

J Korean Med Sci. 2022 Apr 11;37(14):e108. doi: 10.3346/jkms.2022.37.e108.

ABSTRACT

BACKGROUND: The effect of coronavirus disease 2019 (COVID-19) pandemic on public mental health has been increasing. Additionally, the underlying psychological stressors remain unexplored, and few studies have been conducted nationally on the social distancing measures. Therefore, the present study aimed to identify the psychological impacts of the implementation of social distancing measures by analyzing the Internet search trends of major depressive disorder (MDD) symptoms.

METHODS: Using Naver^® Trends’ relative search volumes (RSVs), we analyzed the average search volumes and trend changes of 16 terms, adopted from the Diagnostic and Statistical Manual of Mental Disorders-5 criteria for diagnosing MDD. An interrupted time-series analysis was performed using the data from January 1, 2016 to December 31, 2020. Furthermore, changes in RSVs, according to the intensity of the social distancing measures implemented from January 1 to December 31, 2020, were determined using Wilcoxon rank sum tests.

RESULTS: Of the 16 terms, the search trends of ‘feeling guilty’ (P < 0.001) and ‘wanting to die’ (P = 0.002) showed a significant increase as of February 29, 2020, when the social distancing measures were officially implemented. Additionally, the average search volumes for ‘hopelessness’ (P = 0.003), ‘sexual desire’ (P < 0.001), ‘insomnia’ (P = 0.002), ‘hypersomnia’ (P < 0.001), ‘restlessness’ (P < 0.001), and ‘feeling lethargic’ (P < 0.001) increased significantly. Moreover, gender analysis showed that the average search volume of ‘depressed mood’ (P = 0.033) and the trend of ‘impaired concentration’ (P < 0.001) increased in males only. However, the average search volume of ‘feeling lethargic’ (P = 0.001) and the trend of ‘feeling guilty’ (P = 0.001) increased in females only. The average search volumes for ‘depressed mood’ (P < 0.001), ‘impaired concentration’ (P = 0.038), and ‘indecisiveness’ (P < 0.001) were significantly higher during the enforcement of level 2 or higher social distancing measures.

CONCLUSION: Our results reported the negative effect of COVID-19 preventive measures on public mental health in South Korea, especially for MDD symptoms. Moreover, the findings suggested the utility of Naver Trends as a feasible big data source to assess future mental health crises.

PMID:35411728 | DOI:10.3346/jkms.2022.37.e108

CPT Pharmacometrics Syst Pharmacol. 2022 Apr 11. doi: 10.1002/psp4.12795. Online ahead of print.

ABSTRACT

The coronavirus disease 2019 (COVID-19) has presented unprecedented challenges to the generic drug development including interruptions in bioequivalence (BE) studies. Per guidance published by the US Food and Drug Administration (FDA) during the COVID-19 public health emergency, any protocol changes or alternative statistical analysis plan for COVID-19-interrupted BE study should be accompanied with adequate justifications and not lead to biased equivalence determination. In this study, we used a modeling and simulation approach to assess the potential impact of study outcomes when two different batches of a Reference Standard (RS) were to be used in an in vivo pharmacokinetic (PK) BE study due to the RS expiration during the COVID-19 pandemic. Simulations were performed with hypothetical drugs under two scenarios: 1) uninterrupted study using a single batch of an RS, and 2) interrupted study using two batches of an RS. The acceptability of BE outcomes was evaluated by comparing the results obtained from interrupted studies with those from uninterrupted studies. The simulation results demonstrated that using a conventional statistical approach to evaluate BE for COVID-19-interrupted studies may be acceptable based on the pooled data from two batches. An alternative statistical method which includes a “batch” effect to the mixed effects model may be used when a significant “batch” effect was found in interrupted 4-way crossover studies. However, such alternative method is not applicable for interrupted 2-way crossover studies. Overall, the simulated scenarios are only for demonstration purpose, the acceptability of BE outcomes for the COVID19-interrupted studies could be case-specific.

PMID:35411692 | DOI:10.1002/psp4.12795

Neuropsychopharmacol Rep. 2022 Apr 12. doi: 10.1002/npr2.12250. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aimed to examine the effectiveness of vaccination to improve mental health among employees in Japan based on a prospective study.

METHODS: The data were retrieved from the Employee Cohort Study conducted during the COVID-19 pandemic in Japan (E- COCO-J) at T1 (4-10 February 2021) and T2 (22-29 June 2021). Psychological distress was measured by using an 18-item scale of the Brief Job Stress Questionnaire (BJSQ). The analytic sample was limited to individuals employed at both T1 and T2 without missing covariates. Vaccination status was measured at T2. Statistical analysis was conducted to test the differential change in the psychological distress at T1 and T2 with the time × group interactions by using repeated ANOVA, adjusting for the covariates (gender, age, marital status, education, chronic disease, company size, industry, and occupation).

RESULTS: Of the total sample (N = 948), 105 (11.1%) were vaccinated at least once at T2. The crude mean scores of psychological distress at T1 and T2 were 41.8 and 42.0 for vaccinated participants and 41.2 and 41.2 for nonvaccinated participants, respectively, with no significant effect of having been vaccinated (Cohen’s d = 0.02, P = 0.833). After adjusting the covariates, there was no significance (P = 0.446).

CONCLUSIONS: The COVID-19 vaccination was supposed to have a limited effect on mental health among Japanese employees in an early phase of vaccination. To keep providing mental health care for employees is important even after starting the vaccination program.

PMID:35411665 | DOI:10.1002/npr2.12250

J Paediatr Child Health. 2022 Apr 12. doi: 10.1111/jpc.15975. Online ahead of print.

ABSTRACT

AIM: To determine if the delivery mode has a causal effect on neonatal serum C-reactive protein (CRP) levels. If such a causal effect exists, we aim to quantify its magnitude.

METHODS: We investigated the causal effect of the delivery mode on serum CRP levels 6-8 h after delivery, with appropriate statistical tools for retrospective studies, combining classical and machine-learning methods. The statistical inference is followed by sensitivity analysis to quantify the magnitude of unobserved bias required in order to alter the study’s conclusion.

RESULTS: This retrospective study reviewed laboratory records of neonates after birth who underwent blood tests due to suspected sepsis. A total of 440 newborns were included, 324 of which underwent a vaginal delivery, 59 an urgent caesarean delivery, and 57 an elective caesarean delivery. Our results revealed that serum CRP values following elective caesarean deliveries were 50% less than those following a vaginal delivery (P = 0.030; -0.907; 95% CI [-1.545, -0.268] in log-CRP units). No significant effect was found for urgent caesarean deliveries compared to vaginal deliveries (P = 0.887). Those results were strengthened by (1) a sensitivity magnitude of 1.6 to unobserved bias and (2) non-significant effects when analysis is repeated on blood collected 12-24 h after birth.

CONCLUSION: CRP concentrations in neonatal blood during the first 6-8 h of life are higher following vaginal deliveries compared to elective caesarean deliveries. Further studies with the intent of improving EONS detection should include information on the delivery mode.

PMID:35411656 | DOI:10.1111/jpc.15975

Med Phys. 2022 Apr 12. doi: 10.1002/mp.15669. Online ahead of print.

ABSTRACT

BACKGROUND: Electrical impedance tomography (EIT) is a non-ionizing imaging technique for real-time imaging of ventilation of patients with respiratory distress. Cross-sectional dynamic images are formed by reconstructing the conductivity distribution from measured voltage data arising from applied alternating currents on electrodes placed circumferentially around the chest. Since the conductivity of lung tissue depends on air content, blood flow, and the presence of pathology, the dynamic images provide regional information about ventilation, pulsatile perfusion, and abnormalities. However, due to the ill-posedness of the inverse conductivity problem, EIT images have coarse spatial resolution. One method of improving the resolution is to include prior information in the reconstruction.

PURPOSE: In this work, we propose a technique in which a statistical prior built from an anatomical atlas is used to post-process EIT reconstructions of human chest data. The effectiveness of the method is demonstrated on data from two patients with cystic fibrosis.

METHODS: A direct reconstruction algorithm known as the D-bar method was used to compute a 2-D reconstruction of the conductivity distribution in the plane of the electrodes. Reconstructions using one step in an iterative (regularized) Newton’s method were also computed for comparison. An anatomical atlas consisting of 1,589 synthetic EIT images computed from X-ray computed tomography (CT) scans of 74 adult male subjects was computed for use as a statistical prior. The resolution of the D-bar images were then improved by maximizing the conditional probability density function of an image that is consistent with the a priori information and the statistical model. A new method to evaluate the accuracy of the EIT images using CT scans of the imaged patient as ground truth is presented. The novel approach is tested on data from two patients with cystic fibrosis.

RESULTS AND CONCLUSIONS: The D-bar images resulted in better structural similarity index measures (SSIM) and multi-scale (MS) SSIM measures for both subjects using the mask or amplitude evaluation approach than the one-step (regularized) Newton’s method. Further improvement was achieved using the Schur complement (SC) approach, with MS-SSIM values of 0.718 and 0.682 using SC evaluated with the mask and amplitude approach, respectively, for Patient 1, and MS-SSIM values of 0.726 and 0.692 using SC evaluated with the mask and amplitude approach, respectively, for Patient 2. The results from applying an anatomical atlas and statistical prior to EIT data from two patients with cystic fibrosis suggest that the spatial resolution of the EIT image can be improved to reveal pathology that may be difficult to discern in the original EIT image. The novel metric of evaluation is consistent with the appearance of improved spatial resolution and provides a new way to evaluate the accuracy of EIT reconstructions when a CT scan is available. This article is protected by copyright. All rights reserved.

PMID:35411573 | DOI:10.1002/mp.15669

Clin Anat. 2022 Apr 11. doi: 10.1002/ca.23884. Online ahead of print.

ABSTRACT

Most guidelines fail to specify patient positioning during central venous catheterization. The objective was to determine the effects of head-down tilt (Trendelenburg position) and head rotation on the internal jugular vein (IJV). A prospective, observational, longitudinal, and descriptive study using healthy adult volunteers, of both sexes, was performed. The change in position and cross-sectional areas (CSA) of the right IJV and common carotid artery (CA) were measured by ultrasonography during Trendelenburg position (TP) (0°, 5°, 10°, and 15°) and contralateral head-rotation (HR) (0°, 45°, and 90°) for a total of 12 positions. The neutral supine position was first, randomizing the other 11 positions, with 5-minute rest intervals in between. Vital signs and symptoms were recorded. A total of 54 volunteers were recruited between the ages of 21 and 32, of which 30 were men. Any degree of TP or HR significantly increased the CSA. The largest area obtained was 1.78cm² with a TP15HR90 which did not have a statistical difference with TP10HR45 1.59cm² . A HR90 tended to displace the IJV medially, overlaying the CA. Any degree of TP or HR will significantly increase CSA or the right IJV. A 5° to 10° TP is recommended when the patient’s condition allows it, with a 45° HR, without significantly displacing the IJV anterior to the CCA. This article is protected by copyright. All rights reserved.

PMID:35411564 | DOI:10.1002/ca.23884

Environ Sci Pollut Res Int. 2022 Apr 12. doi: 10.1007/s11356-022-19950-0. Online ahead of print.

ABSTRACT

Understanding the factors affecting R&D trends in the energy sector has a key role in overcoming environmental concerns such as combating climate change, as well as other economic and political problems related to energy. Based on such concerns, this study aims to analyze fundamental factors that determine the energy R&D trends of 29 International Energy Agency (IEA) countries. The data set, consisting of annual indicators for the period 1990-2015, is analyzed with the Driscoll-Kraay panel data estimator. Empirical findings for overall sample show that efficiency, import dependency, and the share of renewable energy use are positively related with R&D expenditure in energy sector. CO₂ intensity is found to be statistically insignificant. When countries are grouped considering their energy composition structures, the dynamics of energy R&D expenditures differ between groups. In overall evaluation, our findings illustrate efficiency and dependency to have greater priority compared to environmental dynamics on energy R&D expenditures for IEA countries during the period.

PMID:35411522 | DOI:10.1007/s11356-022-19950-0

Environ Sci Pollut Res Int. 2022 Apr 11. doi: 10.1007/s11356-022-19896-3. Online ahead of print.

ABSTRACT

At present, the imbalance in regional development and carbon emissions are the two major challenges that China faces in terms of achieving high-quality development. This paper takes regional development differences as the starting point. First, we adopt the improved CRITIC method to measure the comprehensive development level of 30 regions in China and use K-means clustering to divide the 30 regions into five development levels. Second, the structural path analysis for environmental input-output analysis (EIOA-SPA) model is used to quantify the transfer of carbon emissions between sectors in various regions. Finally, a comprehensive analysis is performed based on the development characteristics of each region and the decomposition results of the carbon emission paths. Then, more precise carbon emission reduction strategies are proposed for the development of different regions in China. The results show that first, the development gap between regions in China has improved, and the development of the central and western regions has achieved remarkable results. However, differences between the north and the south and the gap between coastal and inland regions still exist. Second, the direct carbon emissions of regions with different levels of development are mainly derived from high energy-consuming sectors, especially the production and supply of electricity and heat sector. Third, there are certain differences in the indirect carbon emission pathways of regions with different development levels. The transportation, storage, and postal sector in high developed regions have obvious driving effects on carbon emissions. The building sector plays a prominent role in driving carbon emissions in high developed regions and medium-high developed regions. The building sector, nonmetallic mineral products sector, metal smelting sector, and rolled processed product sector in medium developed regions and medium-low developed regions have relatively high carbon emission-stimulating effects. Therefore, it is necessary to adopt differentiated emission reduction strategies for regions with different development levels in China to achieve adequate carbon emission reductions. This effort would further promote the construction of China’s ecological civilization.

PMID:35411515 | DOI:10.1007/s11356-022-19896-3

Pharm Res. 2022 Apr 11. doi: 10.1007/s11095-022-03199-w. Online ahead of print.

ABSTRACT

PURPOSE: Skin sampling by tape stripping measures the local bioavailability of topical drug products in the stratum corneum (SC). The goal of the current study was to evaluate the impact of different investigators in studies that utilize a tape stripping protocol designed to minimize investigator variability.

METHODS: Two open-label clinical studies compared two lidocaine patches and a diclofenac patch and solution in twelve healthy volunteers. The mass of drug was determined in SC samples collected on tape strips at three time points following product removal in duplicate by two investigators. Investigator results were compared with each other and with results for the diclofenac solution measured by another laboratory using a similar protocol.

RESULTS: For drug mass, the geometric mean ratio comparing two investigators is within the acceptable bioequivalence interval for most measurement times and drug products. Drug uptake into the SC from the diclofenac solution was not statistically different from that determined in another laboratory. The average flux from the SC over the clearance intervals for the four drug products correspond well with flux measurements from in vitro permeation tests.

CONCLUSIONS: Results from different investigators are reproducible within the limitations of measurement variability, which can be managed by increasing volunteer numbers.

PMID:35411510 | DOI:10.1007/s11095-022-03199-w

Behav Res Methods. 2022 Apr 11. doi: 10.3758/s13428-022-01815-6. Online ahead of print.

ABSTRACT

The probability of superiority (PS) has been recommended as a simple-to-interpret effect size for comparing two independent samples-there are several methods for computing the PS for this particular study design. However, educational and psychological interventions increasingly occur in clustered data contexts; and a review of the literature returned only one method for computing the PS in such contexts. In this paper, we propose a method for estimating the PS in clustered data contexts. Specifically, the proposal addresses study designs that compare two groups and group membership is determined at the cluster level. A cluster may be: (i) a group of cases with each case measured once, or (ii) a single case with each case measured multiple times, resulting in longitudinal data. The proposal relies on nonparametric point estimates of the PS coupled with cluster-robust variance estimation, such that the proposed approach should remain adequate regardless of the distribution of the response data. Using Monte Carlo simulation, we show the approach to be unbiased for continuous and binary outcomes, while maintaining adequate frequentist properties. Moreover, our proposal performs better than the single extant method we found in the literature. The proposal is simple to implement in commonplace statistical software and we provide accompanying R code. Hence, it is our hope that the method we present helps applied researchers better estimate group differences when comparing two groups and group membership is determined at the cluster level.

PMID:35411476 | DOI:10.3758/s13428-022-01815-6